A review of available prosthetic material for abdominal wall repair

Journal of Visceral Surgery (2013) 150, 52—59

Available online at

www.sciencedirect.com

ORIGINAL ARTICLE

A review of available prosthetic material for abdominal wall repair M. Poussier , E. Denève , P. Blanc , E. Boulay , M. Bertrand , M. Nedelcu , A. Herrero , J.-M. Fabre , D. Nocca ∗ Service de chirurgie digestive A, Hôpital Saint-Eloi, CHU de Montpellier, 80, avenue Augustin-Fliche, 34295 Montpellier cedex 5, France

KEYWORDS Prosthetic material; Abdominal wall repair; Hernia

Summary Abdominal wall incisional and inguinal hernia repair can call for utilization of implants or prostheses as an alternative to simple suture techniques. The various implants can be synthetic, biologic or mixed: their physicochemical properties condition the mechanical results and the long-term outcome of the repair. The increasing number of available materials allows the surgeon to choose between a wide variety depending on the indication, the site of implantation, the surgical approach and whether the operative field is contaminated or not. With regard to evidence-based medicine, while several synthetic implants have been shown to be superior in efficacy to simple suture, other studies are underway to develop the indications for bioprostheses, in particular in contaminated fields. This review of the literature summarizes the current knowledge on synthetic and biologic implants (physicochemical characteristics, forms, indications). © 2012 Published by Elsevier Masson SAS.

Introduction Reinforcing the abdominal wall with an implant during hernia or incisional hernia repair is accepted by all. The French Health Authority (Haute Autorité de santé or HAS) published a study in 2008 showing that reinforcement with implant decreased the recurrence rate (< 1.5%) in comparison to repair without implant [1] (which can be as high as 50% according to the size of the defect) [2]. More than one million implants are inserted worldwide every year. Use of prosthetic material for abdominal wall surgery dates back more than one century. Around 1900, the first prosthesis used for the treatment of inguinal hernia was an inoxidable steel metallic mesh, later abandoned because of its rigidity, responsible for sequellar pain. The modern era started in 1958 with the introduction of polypropylene implants [3]. At the present time, several new implants are available on the market. These are made of textile mono- or multifilaments, woven, knitted or glued in the form of a mesh. Ideally, these implants should be chemically inert, not elicit any inflammatory reaction, not be carcinogenetic, not provoke any allergy, be resistant, easily sterilisable, easy to handle, and inexpensive [2].

∗

Corresponding author. E-mail address: [email protected] (D. Nocca).

1878-7886/$ — see front matter © 2012 Published by Elsevier Masson SAS. http://dx.doi.org/10.1016/j.jviscsurg.2012.10.002

A review of available prosthetic material for abdominal wall repair

Synthetic implants Classification and properties The HAS has classed the abdominal wall implants in three categories: flat, 3-D preformed, and biface implants [1]. However, the distinction between the different implants is greater when their physical properties are taken into account: • long-term physical behavior: elective hernia repair (non contaminated or non-infected field) where nonabsorbable prostheses can be used [1]. Absorbable prostheses (example: Vicryl® ) can be used for emergency repair, in a contaminated or infected field, to reduce the risk of evisceration, but with poor long-term results with regard to hernia recurrence because of the weakness of the connective tissues generated by the insertion of the Vicryl® mesh. More recently, a new generation of absorbable synthetic implants (Gore BioA® ), composed of polymers, is under evaluation. Moreover, some implants associate non-absorbable and absorbable material, in general to obtain a softer or lighter prosthesis or an antiadhesion effect: these are biological products of vegetal (Beta D glucane, cellulose), or animal (collagen, omega3) origin [2]; • grid: the implant can be knitted, woven, thermoformed or present as a film (example: ePTFE or expanded polytetrafluorethylene). The implant is characterized by its thickness, its density (g/m2 ), its porosity and the diameter of the grid; • porosity: porosity determines the tissular reaction of implants. The grid is said to be macroporous when pores are greater than 75 ␮m, and microporous when the pores are less than 10 ␮m. The pores must be at least 75 ␮m to allow penetration of macrophages, ingrowth of fibroblasts, collagen deposition and neovascularization within the pores. Implants with large pores create less tissue reaction and preclude granuloma formation bridging the interstices. Effectively, an isolated inflammatory reaction is generated by each individual fiber; if the implant is microporous, the granulomas blend together, enveloping the implant and providing the implant with rigidity; • resistance: the mechanical resistance of implants must be at least 180 mmHg, that is superior to the maximal abdominal pressure (which can reach 150 mmHg during efforts of coughing); • weight: this parameter depends on the type of polymer and the size of the grid. Heavy-weight prostheses (> 90 g/m2 ) are made by tight braiding with thick, microporous filaments. Light wieght prostheses are composed of thin filaments and/or large macroporous grids (> 1 mm), leading to less inflammatory reaction and more elasticity; • elasticity: this characteristic varies according to whether the implant is light-weight (20—35% at a pressure of 16 N/cm2 ) or heavy-weight (4—16% at a pressure of 16 N/cm2 ). Elastic implants are characterized by a certain degree of freedom on mobile parts of the abdominal wall (example: the groin) while rigid, non-elastic, implants reduce abdominal distension. As an example, a rigid, nearly non-distortable implant might be preferred to repair a recurrent linea alba hernia in a patient with chronic bronchitis, because what is needed is abdominal containment; conversely, inguinal hernia repair would benefit from a light-weight, large grid implant where elasticity would increase patient comfort during movements

53

(flexion of the thigh) and decrease inflammation in an abundantly innervated region; • size: the size of the prosthesis should be adapted to the size of the orifice to be covered. In the treatment of incisional hernia, the overlap should be at least 5 cm in all dimensions [2]. One must not forget the ‘‘shrinkage’’ effect, which translates as in vivo shortening of the implant due to tissular reaction.

Classical implants At the present time, there are three different nonabsorbable implants available that differ by their chemical composition as well as by their plaiting: polypropylene, polyester and expanded polytetrafluoroethylene (nylon meshes have been abandoned because they degrade in the long-term): • polypropylene: hydrophobic, inert, rigid, highly resistant, this basic material is used in most woven prostheses (example: Prolene® , Marlex® ); • polyethylene terephtalate polyester (Dacron): elastic, hydrophilic, woven. These meshes are supple, easy to use, and exist also as ‘‘large grid’’, highly porous woven material (example: Mersutures® ); • expanded polytetrafluoroethylene (ePTFE) (example: Dual Mesh® ). This material is rigid, hydrophobic and its absence of integration by the organism decreases the risk of adherence, but this material is rarely indicated for parietal repair.

Light-weight and extra light-weight implants The concept of light-weight material appeared in 1998 with the commercialization of Vypro® by Ethicon. The basic material was reduced by 30% compared with classical implants while the size of the pores increased (3 to 5 mm vs. < 1 mm for the classical implants). Large grids were therefore used to obtain light-weight prostheses. Later, partially absorbable (50%) implants were obtained either by adding absorbable filament meshes to polypropylene meshes, or coating the polypropylene filaments with absorbable polymers. With this type of implant, the inflammatory reaction is decreased by 70% and healing takes place around each monofilament, not globally. The initial partially absorbable light-weight prostheses were composed of polypropylene + polygalactine 910 (example: Vipro® and Viproll® ) or polypropylene + polyglycapone (example: Ultrapro® ). Polygalactine (Vicryl® ) is absorbed within 6 weeks and polyglycapone (Monocryl® ) within 12 to 20 weeks. These composite implants are supple, easy to use because of their form memory and provoke less inflammation [4]. The other materials used in association with polypropylene include ␤-D glucan (Glucamesh® ), or poly-L-lactic acid (PLLA) (example: 4DDome® ), the goal of which is to accelerate tissue integration. Hernia repair with light-weight prostheses have been noted to decrease the risk of chronic pain [5,6] when the anterior approach is used, and are associated with better tolerance when the laparoscopic approach is used [7].

Biface implants When implants are placed intraperitoneally, as for example, during laparoscopic incisional hernia repair, the face in contact with the abdominal wall should have good

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M. Poussier et al.

Table 1 Cost of implant: implants for abdominal wall reconstruction, suspension, or wrapping. Non-absorbable without tissues or derivatives of biologic origin. Nomenclature

Non-absorbable implant knitted or woven, coated or non-coated

Non-absorbable implant not knitted nor woven

Implant for endoscopic or mini-invasive surgery, anatomic, pre-formed, pre-cut, with positioning system, plugs

Price TIPSa

Surface ≤ 100 cm2 100 cm2 < Surface ≤ 250 cm2 Surface > 250 cm2

Surface ≤ 100 cm2 100 cm2 450 cm2

102.45 D

a

49.7 D 61.44 D 80.49 D

182.94 D 365.88 D 518.33 D 1067.14 D

All prices are net with tax; TIPS: tarif interministériel des prestations sanitaires (Interministerial tariff for health-related acts).

integration characteristics; conversely, the face in contact with the viscera should resist adhesion formation and enhance neoperitoneal formation. The non-absorbable parietal face is usually composed of classical material, often polypropylene; the visceral face can be made of absorbable or non-absorbable material. Absorbable materials include oxidized regenerated cellulose (example: Proceed® ), carboxymethylcellulose, or a porcin cellulose-based film, polyethylene glycol and glycerol (example: Composite Parietex® ) or a bio-absorbable reticulated gel composed of omega-3 fatty acids (C-QURTM ® ). Non-absorbable materials include ePTFE (example: Composix L/P® ; Dual Mesh® ), silicone, polyurethane (example: Intra-Swing Composite® ), or titan. All are inert materials, hydrophobic, non-adhesiogenic, intended to avoid cellular penetration.

Other technical improvements

Table 2 Implant cost: implants for abdominal wall reconstruction, suspension, or wrapping. Resorbable without tissues or derivatives of biologic origin. Nomenclature

Absorbable implant Knitted or woven, coated or non-coated

Price TIPS

Surface ≤ 250 cm2 Surface > 250 cm2

32.17 Da 83.39 Da

a

All prices are net with tax; TIPS: tarif interministériel des prestations sanitaires (Interministerial tariff for health-related acts).

Bioprotheses Nature and physicochemical characteristics of bioprotheses

Regular improvements have been made to facilitate the use of implants. These include: • preformed or precut implants adapted to different techniques. Examples comprise dome-shaped implants (4D Dome® ; Ultrapro Plug® , Perfix plug® ) for the plug techniques; different pre-cut prostheses to allow the passage of the spermatic cord (Lichtenstein technique); meshes that assume the anatomical contours of the inguinal region for the pre-peritoneal technique (example: Swing Mesh 4A® , 3D Max® ); • implants facilitating their fixation: implants furnished with either an auto-adhesive cover (example: Swing Contact® , Adhesix® , Progrip® ) or with thermo-inducted staples (example: Endorollfix® ); • three-dimensional implants theoretically limiting the possibility of migration (example: UHS® , Ultrapro® , 3D patch® , PHS® ); • implants adapted to laparoscopic maneuvering, for example, pre-rolled to facilitate the passage in the trocar (example: Endoroll® ), or with pre-inserted cardinal point sutures (example: Parietex® ).

Collagen is a hemostatic, biodegradable biomaterial that is easy to handle and indispensable for cellular ingrowth. It serves as a scaffold for integration of host tissular regeneration via its architectural organization. The rationale is to guide the healing process and restore the initial host status so that cellular penetration, neovascularization and fibroconnective tissue production can form around the implant [8].

Costs of parietal reinforcement prostheses

Synthesis procedures

The costs of the various prostheses are defined according to a classification based on their constitution and their properties (Tables 1—3).

Several procedures exist for the synthesis of bioprostheses (Tutopatch® , SIS® , Tissue Science® process, etc.); these rely on the same basic steps irrespective of the origin of the tissues. In Europe, the Conformité européenne (CE) marking

Origin of bioprotheses The bioprostheses used in abdominal wall surgery derive from animal (xenogenic) or human (allogenic) tissues. They are constituted by type I, III or IV collagen matrixes as well as sterile acellular elastin produced by decellularization, sterilization and viral inactivation, in order to enhance integration and cellular colonization of the prosthesis by the host tissues.

Concept of ‘‘bioactivity’’

A review of available prosthetic material for abdominal wall repair

55

Table 3 Cost of implant: implants for abdominal wall reconstruction, suspension, or wrapping. Non-absorbable or absorbable containing derivatives of animal origin. Nomenclature

Implant Knitted or woven, coated or non-coated

Price TIPS

Surface ≤ 100 cm2 100 cm2 < Surface ≤ 250 cm2 Surface > 250 cm2

a

248.80 Da 292.70 Da 380.51 Da

All prices are net with tax; TIPS: tarif interministériel des prestations sanitaires (Interministerial tariff for health-related acts).

is delivered for implantable medical devices. Products are divided into four classes (I, IIa, IIb and III) according to their potential health risks; for each of them, precise modalities have been established for conformity evaluation.

Biomechanical characteristics The biomechanical characteristics of prosthetic reinforcement implants are essential to the intrinsic efficacy of ensuring mechanically reliable tissue reinforcement. Deeken et al. [9] recently studied several parameters (physical, thermic, and degradation) in a series of 12 human, porcine and bovine bioprotheses. All the tested prostheses supported a tension of greater than 20 N applied to the attachment sutures; half of them tore when tension exceeded 20 N. Resistance to rupture varied from 66.2 N/cm for Permacol® to 199.1 N/cm for X-Thick AlloDerm® . All the prostheses except Surgiguard® , Strattice® and CollaMend® manifested signs of wear after application of 10 to 30% of a mean stress of 16 N/cm. The reticulated CollaMend® and Permacol® implants have shown better resistance to high temperatures and enzymatic degradation of collagen (by collagenase and metalloproteinases) than the nonreticulated implants.

Reticulation Reticulation or cross-linking is an old procedure (tanning) long used in the leather industry to render skins more resistant to degradation The goal of bioprosthetic reticulation is double: to reduce collagen degradation by the host collagenases, and to increase the durability and decrease the immunogenicity of xenogenic implants [10]. Several types of reticulating agents are used: glutaraldehyde, hexamethylene diisocyanate and 1ethyl-3-(3-dimethylaminopropyl) carbodiimide (EDC). These biological implants were designed with the goal of reinforcing tissues while gradually degrading over time. In vivo, reticulation modifies tissue restructuring and cellular infiltration and increases the duration of the implant before reabsorption [11]. Some authors feel that reticulation limits tissue regeneration because the bioprothesis behaves like non- or very slowly absorbable synthetic prostheses; this may potentially result in a reduced robustness of repaired tissues in the long term [12]. Moreover, reticulated implants may be very immunogenic (macro/monophage activation) and increase the inflammatory response to host tissues (pro-inflammatory cytokines) [13,14]. Clinically, a recent retrospective study, from the database of the Food and Drug Administration (FDA) [15] found that there was a 75% complication rate associated with the use of reticulated bioprostheses, especially when they were used in infected fields (79%) and that their innate tendency to bacterial

colonization was elevated [16]. Encapsulation of reticulated implants, a complication that resembles a graft vs. host rejection reaction, is due to a combination of host inflammatory response, immunogenicity, and to inadequate tissue restructuration due to insufficient tissue integration [15]. When encapsulation occurs, this may lead to decreased quality of tissue repair and necessitate implant removal [17].

Classification At the present time, there is no consensual agreement regarding classification of bioprostheses. Nonetheless, these implants can be classed according to their tissue origin, the process of synthesis (reticulation), and their indications. Although less than exhaustive,Table 4 lists the bioprostheses in use throughout the world for abdominal and reconstructive surgery.

Rationale for bioprosthesis placement Insertion of synthetic material for tissue reinforcement in an infected or contaminated field is contra-indicated because there are major risks of chronic infection, rejection or recurrence [18]. Nonetheless, there are indications for the use of temporary interfaces between infected tissues that are desirable, if not indispensable, even in the contaminated field. In order to respond to this challenging problem, new implantable medical devices began to be introduced in the 1980s [19]. The rational for these bioprostheses resided in their progressive biodegradability and their supposedly weak immunogenicity, while still ensuring high quality tissue regeneration with mechanical characteristics similar to synthetic prostheses. Among others, Milburn et al. [20] showed in the rodent experimental model that the acellular dermal collagen matrix (AlloDerm® ) had better resistance to Staphylococcus aureus inoculation compared with PTFE for incisional hernia repair; the bacterial clearance was 19.3% versus 0%. These results were confirmed by Harth and co-workers [21] who compared the bacterial clearance of a S. aureus innoculum (104 CFU/ml) injected after parietal repair with prosthetic reinforcement comparing four bioprotheses (Surgisis® , Permacol® , XenMatrix® , Strattice® ) versus a synthetic polyester implant. Bacterial clearance was 0% for synthetic material, 58% for Surgisis® , 67% for Permacol® , 75% for XenMatrix® and 92% for Strattice® (P = 0.003). This confirms the value of the use of bioprostheses in infected fields; the ultimate outcome depends on the type of implant. The indications for bioprostheses have progressively increased, even though there have been only a few preclinical and clinical studies with high levels of evidence

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M. Poussier et al.

Table 4

Summary of the principal studies of interest concerning the placement of bioprostheses. Contaminated or infected operative field

Indications

Mean follow-up (months)

Diaz et al. [38] 240

Yes

Multiple

10

RO

Chavarriaga et al. [17]

18

No

Incisional hernia

7.8

Permacol®

RC

Cobb et al. [24]

55

No

Incisional hernia

—

Strattice®

PO

Shaikh et al. [26] Hsu et al. [25]

20

No

18

28

Yes

12

Commercial name of prosthesis

Study type

Authors

AlloDerm®

RO

CollaMend

®

Number of cases

PO

Itani et al. [30]

85

Yes

Incisional hernia Incisional hernia Hernia

Surgisis®

PR

Ansaloni et al. [33]

35

No

Hernia

36

Veritas®

PO

Franklin et al. [32] Helton et al. [34] Ueno et al. [35] Limpert et al. [36]

116

Yes

Multiple

52

53

Yes

14

20

Yes

Incisional hernia Multiple

22

Yes

Incisional hernia

22

Pohamac et al. 16 [39]

Yes

Incisional hernia

16

RO

RO RO RO XenMatrix®

RO

Commercial name of prosthesis

AlloDerm® CollaMend Permacol Strattice

®

®

®

Surgisis® Veritas

®

XenMatrix®

16

15

Complications Global (%) Recurrent hernia (%)

Seroma (%)

Infection Dehiscence (%) (%)

Fistula (%)

Removal of prosthesis (%)

86.7

17.1

31

40

8.8

11.6

—

38.9

44.4

—

22.2

—

—

22.2

—

6.6

—

3.3

—

—

1.8

40 21 67

15 10.7 15

10 14.3 22

10 3.5 23

5 3.5 15

— — 2.5

— 0 0

33

0

17.1

2.9

—

—

—

— 50 50 23

7 17 30 19

9.4 11 10 3.8

— — 40 3.8

— 21 — —

— — — —

— 32 — —

36

7

21

7

7

—

6.2

RO: retrospective observational; RC: retrospective controlled; PO: prospective observational; PR: prospective randomized.

to evaluate their efficacy compared with four times as many publications about implantation of these prostheses in uncontaminated fields [22].

bioprostheses is not allowed in France. Nonetheless, they are widely used in the United States where they recently obtained the authorization from the FDA in spite of the lack of reference studies.

Evidence-based medicine and bioprostheses Allogenic bioprotheses

AlloDerm®

Allogenic protheses are produced using the dermis or fascia lata of cadaver donors (Table 4). Commercialization of these

The bioprosthesis AlloDerm® , a non-reticulated sterile acellular collagen matrix derived from human dermis, is the

A review of available prosthetic material for abdominal wall repair

57

most widely studied product (547 references) and has been implanted in more than one million procedures.

soon (Nocca et al. presented the results in the EHS congress Ghent 2011).

AlloMaxTM

Veritas® TM

TM

The bioprosthesis AlloMax (formerly Neoform ) is a nonreticulated sterile acellular collagen matrix derived from human dermis used for post-mastectomy reconstruction. AlloMaxTM can be indicated for complex inguinal or incisional hernia repair in patients where synthetic prostheses are contraindicated or inappropriate.

Flex HD® Acellular Hydrated Dermis The bioposthesis Flex HD® Acellular Hydrated Dermis is a non-reticulated sterile acellular collagen matrix derived from human dermis provided by a donor bank (Musculoskeletal Transplant Foundation); it is used for post-mastectomy reconstruction or repair of complex hernia or incisional hernia.

Xenogenic bioprostheses Xenogenic prostheses can be of porcine (dermis or intestinal mucosa) or bovine (pericardium) origin, reticulated or not. There are more than 20 commercial products available, but in France, only six products have received the CE marking and been studied in clinical trials, albeit with a low level of evidence (Table 4).

CollaMend® This bioprosthesis is composed of reticulated porcine dermis and has been evaluated in three clinical studies, two of which were retrospective [17,23].

Permacol® This bioprosthesis, originating from reticulated porcine dermis, was evaluated in 110 references, of which 37 were clinical studies: two retrospective studies can be considered of value [24,25] while the level of evidence was low in four prospective studies [26—29].

Strattice® This bioprosthesis, originating from non-reticulated porcine dermis, has been evaluated in 19 references including four preclinical studies (one being a retrospective case report and one, a review of the literature, six clinical cases in all) and four ongoing clinical studies one of which is a multicenter study for ventral hernia: the ‘‘RICH’’ study (for use in infected fields) [30]. A prospective multicenter tripleblinded randomized controlled study comparing the use of Strattice® vs. a synthetic prosthesis for primary inguinal hernia in 170 male patients with an average follow-up of 2 years is underway and should provide interesting data concerning the behavior of these bioprostheses [31].

Surgisis® or Biodesign® This bioprothesis, composed of non-reticulated porcine intestinal mucosa, was the object of 800 published articles (all domains) of which 614 were preclinical studies and 211 clinical (case reports, retrospective series); only one was a long-term (5 years) prospective study [32] concerning laparoscopic hernia repair in contaminated fields while three retrospective studies were deemed of value [33—35].

Tutomesh® or Tutopatch® This non-reticulated bovine pericardial bioprosthesis was studied in more than 90 publications (all domains) including eight preclinical studies and the first multicenter prospective randomized trial ‘‘Protocole Tutomesh® ’’ comparing the efficacy of this bioprosthesis in contaminated or infected fields vs. traditional suture techniques; this will be published

This non-reticulated bovine pericardial bioprosthesis was studied in 20 publications (all domains) including four preclinical and 14 clinical studies [36].

Protexa® This bioprosthesis, originating from porcine dermis, has been commercialized in France since 2012. A multicenter study is underway in Italy.

Comparative studies between prostheses After initial feasibility and efficacy studies, several bioprostheses have been compared among themselves. In their retrospective study, Shah et al. [23] compared the use of five different bioprostheses (AlloDerm® , Permacol® , CollaMend® , Surgisis® and Strattice® ) for complex abdominal incisional hernia repair in 58 patients. They found an overall complication rate of 72.4% including 19% infections, 8.6% seromas and 5.2% abscesses. Reticulated bioprostheses (Permacol® , CollaMend® ) had higher infection and removal rates but lower recurrence rates compared with non-reticulated bioprostheses. Hiles et al. [22] found a 6.7% recurrence rate for Surgisis® versus 13.6% for AlloDerm® at 16 months in clean environment repair.

Cost/effectiveness There are practically no cost-effectiveness studies available for these bioprotheses. In 2008, Blatnik et al. [37] estimated that the average cost for parietal reconstruction in an infected field with AlloDerm® was 5330 dollars per patient (4100 euros) not including hospital costs, with a hernia recurrence rate of 80%. By comparison, the average costs are 53 euros/patient for synthetic Prolene® prostheses (Ethicon), 79 euros/patient for Vicryl® (Ethicon), and 237 euros/patient for the composite Parietex® (Sofadim/Bard) prosthesis.

Safety — Informed consent As is the case for implantable medical devices, bioprostheses respond to the health criteria relative to their utilization according to the country in which they are commercialized (premarket approval [PMA] and 510k of the FDA, EC marking in Europe). These requirements are supposed to guaranty the safety of the product for the patient, in particular viral infectious, prion and cancerogenic risks. Despite all these precautions, results of preclinical studies with regard to harm are rare and not clear. Along the same lines, and according the French law of March 4, 2002, patients must receive complete information concerning the use of bioprostheses, especially as concerns the tissue origin of the product, both for ethical reasons and to respect each patient’s personal convictions.

Conclusion The surgeon has to choose the correct implant according to its properties and the clinical picture. In any case, the procedure should never be adapted to the product available, which implies that the surgeon should have a wide range of products at his or her disposal. The important parameters to take into account include: the size and site of the defect

58 to cover, the rigidity of the implant, the potential contamination of the operative field, the need or desire for cellular ingrowth, and the surgical approach; the cost-efficacy ratio based on similar services should not be ignored. Synthetic implants have been widely studied and their efficacy proven for individual indications. Bioprostheses should have their place in the therapeutic armamentarium of abdominal and reconstructive surgery, in particular, in complex situations where the parietal reinforcement has to be made in potentially contaminated or infected fields. The results of the first multicenter prospective randomized study in France comparing the efficacy of Tutomesh® versus simple suture repair for the treatment of inguinal or incisional hernia in potentially contaminated or infected field are awaited.

M. Poussier et al.

[15]

[16]

[17]

[18]

[19] [20]

Disclosure of interest The authors declare that they have no conflicts of interest concerning this article.

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